Trastuzumab Appeals Update

Last week, several briefs were filed in Federal Circuit appeals relating to trastuzumab biosimilars:

Trastuzumab IPR Appeals

On September 3, 2019, the USPTO submitted responsive appellate briefs in Federal Circuit appeals from IPR final written decisions regarding two patents related to methods of treating HER2+ cancer with trastuzumab (Cases Nos. 19-1263, 19-1265, 19-1267, and 19-1270). Genentech had argued in its opening briefs that the PTAB erred as a matter of law in finding the claims of Genentech’s U.S. Patent Nos. 7,846,441 and 7,892,549 to be unpatentable on obviousness grounds, including by misconstruing certain claim terms, and, in some instances, denying Genentech’s motion to amend its claims (19-1263, 19-1265, 19-1267, 19-1270). The USPTO intervened in the appeals to step in for IPR petitioners Celltrion, Pfizer and Samsung Bioepis after they withdrew in view of settlements. In its responsive briefs, the USPTO defended the PTAB’s decisions across the board. Genentech’s reply briefs are due on October 15, 2019.

Trastuzumab PI Appeal

On September 4, 2019, Amgen filed its responsive appellate brief in Genentech’s interlocutory appeal to the Federal Circuit from the district court’s denial of Genentech’s motion for a preliminary injunction to enjoin Amgen’s sales of KANJINTI (trastuzumab-anns). Most of Amgen’s brief to devoted to reiterating the points it successfully made to the district court—that Genentech’s delay in seeking injunctive relief and pattern of granting licenses negated a finding of irreparable harm. Genentech’s reply brief is due by September 25.

Meanwhile, the parties’ BPCIA litigation (from which this interlocutory appeal stemmed) remains in discovery. Recently, Genentech filed a new amended complaint to reflect the state of Genentech’s allegation in view of stipulations of dismissal of certain originally asserted patents. Genentech had originally asserted 37 patents against Amgen, but its case is now down to nine patents (including the ’441 and ’549 patents, discussed above).